ASTM E1104 - 98(2009)

    Standard Specification for Clinical Thermometer Probe Covers and Sheaths

    Active Standard ASTM E1104 | Developed by Subcommittee: F04.33

    Book of Standards Volume: 13.01


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    Abstract

    This specification covers all single-use clinical thermometer probe covers and sheaths intended for use with any clinical thermometer. Requirements are given for safety, toxicity, handling, labeling, and physical integrity. Testing procedures for appropriate requirements and a glossary of terms used are provided. Toxicity test, leakage test, and compatibility test shall be performed to meet the requirements prescribed.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    1. Scope

    1.1 This specification covers all single-use clinical thermometer probe covers and sheaths intended for use with any clinical thermometer. Requirements are given for safety, toxicity, handling, labeling, and physical integrity. Testing procedures for appropriate requirements and a glossary of terms used within the standards are provided.

    1.2 The requirements contained herein are intended to ensure adequate isolation of the patient from the temperature-measuring device. In addition, the safety and health of the patient shall not be adversely affected. When used in accordance with the manufacturers instructions, the probe cover, sheath, and temperature measuring device shall remit correct temperature readings as required in Specifications E 667 and E 1112.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    E344 Terminology Relating to Thermometry and Hydrometry

    E667 Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers

    E1112 Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature


    ICS Code

    ICS Number Code 11.040.99 (Other medical equipment); 17.200.20 (Temperature-measuring instruments)

    UNSPSC Code

    UNSPSC Code 42182205(Medical thermometer tip or probe covers)


    DOI: 10.1520/E1104-98R09

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